Rosci v. AcroMed, Inc.
| Decision Date | 19 December 1995 |
| Citation | 669 A.2d 959,447 Pa.Super. 403 |
| Parties | , 30 UCC Rep.Serv.2d 141, Prod.Liab.Rep. (CCH) P 14,489 Ronald ROSCI and Kimberly Rosci, H/W v. ACROMED, INC. Ronald ROSCI and Kimberly Rosci, H/W v. THOMAS JEFFERSON UNIVERSITY HOSPITAL, and Sanford H. Davne, M.D., Donald L. Myers, M.D., and Edwin Ferrin, M.D. |
| Court | Pennsylvania Superior Court |
Joseph L. Messa, Jr. and Mark W. Tanner, Philadelphia, and Thomas W. Sheridan, Downington, for appellants.
Louis A. Bove, Philadelphia, for Acromed, Inc., appellee.
Mark Herrmann, Pro Hac Vice, Cleveland, Ohio, for Acromed, Inc., appellee.
Michael D. Fishbein, Philadelphia, for Legal Committee in MDL 1014, Amicus Curiae.
Before McEWEN, TAMILIA, and KELLY, JJ.
Appellant, Ronald Rosci, injured his back in 1986 and was diagnosed by Donald L. Myers, M.D., a neurosurgeon, and Sanford Davne, M.D., an orthopedic surgeon, as suffering from two herniated discs of his lumbar spine. Appellant underwent L3-4 and L4-5 diskectomies with an L/3/4/5 fusion on November 11, 1986, during the course of which Dr. Davne removed the two discs between the lumbar vertebrae and implanted VSP nested bone plates and cancellous bone screws, manufactured by appellee AcroMed Corporation and sold under the trade name "VSP bone plates" and "VSP bone screws", as temporary aids to healing so that the three vertebrae abutting the disc spaces would fuse. Dr. Davne testified in his deposition that he was aware that the VSP bone plates and screws had been approved by the FDA for use only as fixation devices in the long bones and that his use was an "off-label" use. See: Reeves v. AcroMed Corp., 44 F.3d 300, 305 (5th Cir.1995). Dr. Davne also testified that he was aware of the warnings, contained in the package with the bone plates and screws, which provided:
WARNINGS, PRECAUTIONS, AND ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES
1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.
2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree of success of union loads produced by weight bearing and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches, or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.
3. MIXING METALS CAN CAUSE CORROSION. There are many levels of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel accelerates the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc. which come into contact with other metal objects must be made from like or compatible metals.
4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure.
A. The patient's weight. An overweight or obese patient can produce loads on the device which can lead to failure of the appliance and the operation.
B. The patient's occupation or activity. If the patient is involved in an occupation or activity which includes substantial walking, running, lifting or muscle strain, the resultant forces can cause failure of the device.
C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected usefulness of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief.
E. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation.
1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.
2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper bending equipment. The operating surgeon should avoid any notching, scratching, or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the local point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause failure.
3. REMOVAL OF THE IMPLANT AFTER HEALING. Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.
4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient's ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in premature failure of metallic internal fixation devices by loosening, bending, or fracture. The patient should understand that a metallic implant is not as strong as normal healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation.
1. Nonunion, delayed union
2. Bending or fracture of implant. Loosening of the implant.
3. Metal sensitivity, or allergic reaction to a foreign body.
4. Infection.
5. Decrease in bone density due to stress shielding.
6. Pain, discomfort, or abnormal sensations due to presence of the device.
7. Nerve damage due to surgical trauma.
8. Bursitis.
9. Dural leak.
10. Paralysis.
11. Death.
A diagnostic x-ray taken of Mr. Rosci approximately four months after the surgery revealed that two of the bone screws had broken in place, that one of the bone plates had shifted and bent, and that the vertebrae had not fused. Appellant, permanently disabled as a result of the failure of the bone to fuse, filed a medical malpractice action against Dr. Davne, Dr. Myers, and Thomas Jefferson Hospital and, more than one year thereafter, instituted the instant action against AcroMed seeking damages based upon strict liability, 1 negligence, 2 and breach of implied and express warranties. 3 All of the claims against AcroMed, other than those based on breach of warranty, were dismissed by the trial court on motion of appellee based upon the expiration of the applicable statute of limitations, 42 Pa.C.S. § 5524, and the malpractice action has been resolved. AcroMed then filed a motion seeking summary judgment in its favor on the remaining claims, contending that the claims based on implied and express warranties were preempted by the Medical Device Amendments of 1976 (the "MDAs"), 21 U.S.C. §§ 360c et seq., to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. AcroMed argued in the alternative that the warranty claims were also barred by virtue of the learned intermediary doctrine.
The learned Judge Sandra Mazer Moss granted the motion of AcroMed for summary judgment, finding that, although the breach of warranty claims of appellants had not been preempted, the warranty claims were barred as a result of the learned intermediary doctrine. For the reasons that follow, we affirm in part and reverse in part the order which granted summary judgment in favor of AcroMed.
Rule 1035 of the Rules of Civil Procedure provides, in relevant part:
(a) After the pleadings are closed, but within such time as not to delay trial, any party may move for summary judgment on the pleadings and any depositions, answers to interrogatories, admissions on file and supporting affidavits.
(b) The adverse party, prior to the day of hearing, may serve opposing affidavits. The judgment sought shall be rendered if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, shows...
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